NCT04871828

Brief Summary

There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected intervention was based on that zafirlukast will have dual effect; first it will block the virus replication through inhibiting the COVID19 helicase that is involved in virus replication and secondly by reducing the inflammation through antagonizing the leukotriene receptor. The purpose of this study is to evaluate the clinical efficacy and safety of Leukotriene receptor antagonist in the treatment of moderate cases of COVID-19 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 1, 2021

Last Update Submit

May 5, 2021

Conditions

Moderate Covid19

Outcome Measures

Primary Outcomes (1)

  • Time to clinical improvement,

    The time from symptoms resolved: No fever for 72 hours, no cough, no SOB or live discharge from the hospital, whichever came first.

    28Day

Secondary Outcomes (4)

  • Escalate therapy.

    28Day

  • PCR test

    Day14

  • Length of hospital stay.

    28Day

  • Duration of fever

    28Day

Study Arms (2)

Treatment

EXPERIMENTAL

Zafirlukast plus the standard treatment according to Saudi CDC protocol (combination experimental arm) Description of investigational drug Zafirlukast is leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma. It is available as a tablet and is usually dosed twice daily. It is approved by USFDA and currently commercially marketed under the name of Accolate 20 mg oral tablet. The drug will be acquired from the pharmacy and will be received by the patient during the hospital admission via research coordinator. The study drug will be stored in at room temperature (15 - 25 c) in the hospital's pharmacy and a delegated pharmacist will be responsible for dispensing and return of any drugs. The study drug will be administrated to the patient in the dose of 20 mg orally twice daily for 10 days (fixed dose with no staring or escalating dose).

Drug: Leukotriene Receptor Antagonist

Control

PLACEBO COMPARATOR

placebo plus the standard treatment according to Saudi CDC protocol

Other: Placebo

Interventions

Leukotriene Receptor AntagonistDRUG

Zafirlukast

Treatment
PlaceboOTHER

Placebo

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 years or above
  • Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
  • Able to sign the consent form and agree to clinical samples collection
  • Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB)
  • Admitted to the hospital (outside the ICU)
  • Patients had to be enrolled within 10 days of symptoms onset.
  • willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

  • Asthmatic patient using antiasthma medications
  • Being in the hospital or in home isolation for more than 72 hours before the start of the study drug.
  • Known sensitivity/allergy to the study drug
  • Pregnancy
  • Patient refused
  • Chronic liver disease
  • Severe mental disorder
  • Unstable patients requiring ICU admission
  • Participating in other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Medical city, MNGHA

Riyadh, 11426, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Leukotriene Antagonists

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized placebo-controlled double-blinded clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 4, 2021

Study Start

February 28, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations

SA(1)